# C_2018436EN.01005201.xml

| 3.12.2018 | EN | Official Journal of the European Union | C 436/52 |
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3.12.2018

EN

Official Journal of the European Union

C 436/52

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Action brought on 19 September 2018 — Hexal/EMA

(Case T-549/18)

(2018/C 436/74)

Language of the case: English

Parties

Applicant: Hexal AG (Holzkirchen, Germany) (represented by: M. Martens, N. Carbonnelle, lawyers and S. Faircliffe, Solicitor)

Defendant: European Medicines Agency (EMA)

Form of order sought

The applicants claim that the Court should:

| — | declare that the plea of illegality raised by the applicant against the conclusion of the CHMP that Sanofi’s Teriflunomide has NAS status, as quoted in the Commission decision of 26 August 2013 granting marketing authorization for ‘AUBAGIO® — Teriflunomide’, is admissible and well founded; |
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declare that the plea of illegality raised by the applicant against the conclusion of the CHMP that Sanofi’s Teriflunomide has NAS status, as quoted in the Commission decision of 26 August 2013 granting marketing authorization for ‘AUBAGIO® — Teriflunomide’, is admissible and well founded;

| — | annul the decision of EMA of 5 July 2018 not to validate the Hexal’s MA application for a generic version of the medicinal product Aubagio®; |
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annul the decision of EMA of 5 July 2018 not to validate the Hexal’s MA application for a generic version of the medicinal product Aubagio®;

| — | order the EMA to pay the costs. |
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order the EMA to pay the costs.

Pleas in law and main arguments

The contested decision refuses to validate Hexal’s marketing authorisation application for Teriflunomide Hexal, given that Aubagio®, a previously authorised medicine still benefits from regulatory data protection, according to the Commission implementing decision of 26 August 2013, against which the applicant raises an exception of illegality under Article 277 TFEU. In support of the action, the applicant relies on two pleas in law:

| 1. | Under a first plea in law against the challenged decision of the European Medicine’s Agency, Hexal submits that, the exception of illegality being well-founded, the statement of reasons of the contested decision is not legally admissible because the EMA erred in fact and law and failed to fulfil its duty to state reasons and to perform a careful and thorough assessment, as provided under Article 296 TFEU; |
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1.

Under a first plea in law against the challenged decision of the European Medicine’s Agency, Hexal submits that, the exception of illegality being well-founded, the statement of reasons of the contested decision is not legally admissible because the EMA erred in fact and law and failed to fulfil its duty to state reasons and to perform a careful and thorough assessment, as provided under Article 296 TFEU;

| 2. | Under a second plea in law, the legality of the challenged decision is also contested given that the ‘new active substance’ status should have been examined again upon the filing of Hexal’s generic market authorisation application, which was not the case. Thus, the EMA has allegedly failed to perform its duties appropriately, in particular its duty to perform an effective and careful assessment and to state reasons, pursuant to Article 296 TFUE, which in turn renders the contested decision illegal. |
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2.

Under a second plea in law, the legality of the challenged decision is also contested given that the ‘new active substance’ status should have been examined again upon the filing of Hexal’s generic market authorisation application, which was not the case. Thus, the EMA has allegedly failed to perform its duties appropriately, in particular its duty to perform an effective and careful assessment and to state reasons, pursuant to Article 296 TFUE, which in turn renders the contested decision illegal.

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